Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The early traumatic brain injury-related death in the hospital
研究概览
简要总结
Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Less than 18 years old
- •Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan
- •Time of admission within 3 hour of injury.
排除标准
- •Patient Known pregnancy.
- •patient had Cardiac arrest prior to randomization
- •GCS score of 3 with bilateral unresponsive pupils
- •Known bleeding/clotting disorders.
- •Known seizure disorders.
- •Known history of severe renal impairment
- •Unknown time of injury
- •Prior TXA for current injury
- •Known venous or arterial thrombosis
研究组 & 干预措施
TXA dose A arm
Subjects will receive a 15 mg/kg bolus of Tranexamic acid over 20 minutes followed by 2 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 1000 mg, the maximum rate of infusion is 50 mg/min, and the maximum total maintenance dose is 1000 mg
干预措施: Tranexamic Acid (TXA) (Drug)
TXA dose B arm
Subjects will receive a 30 mg/kg bolus of Tranexamic acid over 20 minutes followed by 4 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 2000 mg, the maximum rate of infusion is 100 mg/min, and the maximum total maintenance dose is 2000 mg
干预措施: Tranexamic Acid (TXA) (Drug)
Placebo arm C
Subjects in the placebo group will receive a bolus dose of normal saline over 20 minutes followed by a normal saline infusion over 8 hours (in the same weight-based volume as the other study arms)
干预措施: Normal saline (Drug)
结局指标
主要结局
The early traumatic brain injury-related death in the hospital
时间窗: 24 hour and 48 hour after injury
2. Decreasing the rate of early head injury-related death (within 24 hour after injury)
The difference between treatment group in the Intracranial haemorrhage growth
时间窗: 24 hour
We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan
The difference between the treatment groups in the incidence of mortality
时间窗: 28 days
Decreasing the rate of head injury-related death in hospital within 28 days of injury all-cause and cause-specific mortality, disability, vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism)
次要结局
- Need for neurosurgical management(28 day)
- Days in the intensive care unit(28 day)
- Need for blood transfusion(48 hour)
- Adverse events(28 days)
- Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)(6 months)
- Pediatric Quality of Life (PedsQL)(6 months)
研究者
Noha Mansour
Lecturer of Clinical Pharmacy- Faculty of Pharmacy - Mansoura University
Mansoura University